Vaginal probe; in particular for treating incontinence

ABSTRACT

The invention relates to a vaginal probe, in particular for treating incontinence and comprising an external part ( 20 ), an internal part ( 22 ), a bridge ( 24 ) connecting said parts and processing electronics ( 28 ). The external part ( 20 ) is configured as a handle and has a cavity ( 26 ) and the internal part ( 22 ) is a body that is rounded on all sides. Said body: a) has sensors ( 44–51 ) on its surface, which are connected to the processing electronics ( 28 ); b) is symmetrical about a longitudinal central plane ( 32 ), which runs between the legs of a patient using said probe; c) has cross-sections that are perpendicular to said longitudinal central plane ( 32 ) and to the bridge ( 24 ), in which the measured height dimension H of said body, which runs parallel to the longitudinal central plane ( 32 ), is at maximum half its measured width B, which runs perpendicular to the longitudinal central plane ( 32 ); and d) has a front sub-section ( 36 ) that is at a distance from the external part ( 20 ), a central section ( 38 ) and a rear sub-section ( 40 ). Said central section ( 38 ) is curved, the rear sub-section ( 40 ) is connected to the bridge ( 24 ) and the front sub-section ( 36 ) and the rear sub-section ( 40 ) are interconnected in one piece by means of the central section ( 38 ) and are at an angle of between 170 DEG–100 DEG in relation to one another.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application forms the national phase of PCT/DE03/00884, filed Mar.18, 2003, which claims the benefit of German Application No. 102 12832.4, filed Mar. 19, 2002.

BACKGROUND OF THE INVENTION

Urinary and faecal incontinence are frequent diseases the frequency ofwhich increases with age. It is assumed that about 2% of the populationsuffer from urinary and/or faecal incontinence. With age, thispercentage increases to more than 10%. Usually, the affected patientsare using management means such as pads and diapers. In the long run,this entails considerable costs.

It is known that incontinence, more specifically stress incontinence,can be treated by training the pelvic floor muscles. Prior art vaginalprobes, which are also called introitus probes, are known, said probesbeing introduced into the vagina and having electrodes for registeringthe electrical activity, what is termed the EMG signal, of the pelvicfloor upon contraction of the pelvic floor muscles. These vaginal probeshave also already been utilized in such a manner that their sensors,which are configured in the form of electrodes, deliver a voltage thatstimulates the muscles to contract. It is also known to use vaginalprobes in what are termed biofeedback applications, the reader beingreferred in this context to DE 19706042 C2. Hereby, the electrodes ofthe vaginal probe record potentials of the body. These potentials areamplified in the form of a signal that is visually or acousticallyreturned to the female patient. As a result, the female patient learnsto selectively control her body functions on her own. This isadvantageous, more specifically if the training is to be performed athome. As to prior art, the reader is generally referred to the Germanmagazine Geburtsk. u. Frauenheilk. (obstetrics and gynecology) 58 (1998)581 to 587 “Das Oberflächen-EMG der Beckenbodenmuskulatur(Introitus-EMG) bei kontinenten und inkontinenten Frauen” (Thesurface-EMG of the pelvic floor muscles (introitus-EMG) in continent andincontinent female patients).

The prior art vaginal probes are configured to exhibit rotationalsymmetry, meaning they have a round cross section. In this context, thereader is also referred to the already mentioned German magazine thatshows an illustration of such an introitus probe. It is connectable to acontrol apparatus via a cable. In many models, the cross section variesover the length of the internal portion. The electrodes also exhibitrotational symmetry and are accordingly configured to be rings,longitudinal electrodes or caps. The rotary position in which theseprior art vaginal probes are introduced into the vagina is no concern.These electrodes only register a mean value of the individualpotentials.

The prior art vaginal probes have considerable disadvantages. As theelectrodes are arranged with rotational symmetry, the various musclegroups it would be desirable to register cannot be scanned directly sothat the already mentioned mean is taken over a larger sized area and,as a result thereof, in most cases over different muscle groups.

Furthermore, the previously known vaginal probes are unpractical inthat, on the one side, they are connected to the control apparatusthrough the supply line, which is inconvenient in practical use, andthat, on the other side, they are also susceptible to slip out wheninserted, more specifically while walking. As a result, the use of theprior art vaginal probes in the normal home setting, be it in standing,walking or any other position, is rendered more difficult.

SUMMARY OF THE INVENTION

The vaginal probe with or without sensors can also directly serve as apessary and, as a result thereof, for conservative treatment of stressincontinence. Such a pessary is inserted by the incontinent woman andits lower portion then exerts a mild pressure onto the urethra, saidpressure increasing in stress situations (continence pessary).

The pelvic floor includes the pelvic diaphragm and the urogenitaldiaphragm. The pelvic diaphragm consists of striated (voluntary) musclesand of the surrounding fasciae (Fascia diaphragmatic pelvis superior etinferior). The pelvic floor muscle is made up of two components, the M.levator ani and the M. puborectalis. From a functional point of view, itmakes no sense to further subdivide the M. levator ani. The M.puborectalis as sphincter pubovisceralis helps in keeping the urethraand the rectum closed.

This is where the invention comes in. It is its object to indicate avaginal probe that is capable of adding to the patient's comfort and ismore specifically manufactured in such a manner that it finds good clearhold in the vagina, meaning that it will not slip out during walking forexample, and that is inserted with a clear orientation. Additionally, adevelopment thereof should offer the possibility to selectively registerthe potentials of individual muscles.

This object is solved by a vaginal probe having an external portion, aninternal portion, a crosspiece for joining these two portions together,with the external portion being configured as a handle and the internalportion being a generally rounded body that a) is oriented symmetricalabout a longitudinal center plane that is oriented between the legs ofthe female patient when inserted, b) comprises across said longitudinalcenter plane and across said crosspiece cross sections in which itsheight dimension H, which is determined parallel to the longitudinalcenter plane, is at most half its width B, which is determined acrosssaid longitudinal center plane, and c) comprises a front subsectiondistal from the external portion, a central section and a rearsubsection, the central section being curved, the rear subsection beingconnected to the crosspiece, said front subsection and said rearsubsection being integrally joined together through the central sectionand said front subsection and said rear subsection being inclined toeach other at an angle of 170°–120°.

The great advantage of this vaginal probe is that it optimally conformsto the natural shape of a vagina. It does not exhibit rotationalsymmetry but is substantially flat. As a result, the positioning thereofinside the vagina is imposed, the internal portion forming, inaccordance with its outer shape, a volume in the vagina.

The internal portion of the vaginal probe is composed of the frontsubsection, the central section and the rear subsection, all of thesethree subsections being integrally joined together with smoothtransitions. The front and the rear subsections are inclined to eachother at an angle of between 180° and 100°. This conforms to the actualanatomy of a woman. (In a standing woman), the vagina first risesvertically before it bends over the pelvic diaphragm to extend as far asthe spine. The rear subsection is associated with the lower verticalportion of the vagina. The front subsection is associated with thesection located above the inclination described. It is not necessary toadapt the shape of the vaginal probe to the actual circumstances. Thefront subsection can be implemented, and is implemented, in such amanner that the internal portion is prevented as far as practicable fromslipping out. It is more specifically the bend described to be providedin the internal portion that prevents the probe from slipping out as itensures a good fit and hold. A relative large surface of the internalportion including its larger overall length as compared to prior artprobes is also advantageous. A relatively large surface is thus providedfor adhesion, which also prevents the probe from slipping out. Thelength of the introitus probe in accordance to the magazine mentionedherein above is about 60 to 65 mm. The length of the internal portion ofthe vaginal probe of the invention is at least one centimeter longer andtypically is about 80 mm.

The internal portion of the vaginal probe in accordance with theinvention is longer than the corresponding prior art apparatus, thisextra length being provided by the front subsection.

Generally, the internal portion accordingly has a shape that effects adefinite position within the vagina. As contrasted with the prior artprobes, the internal portion will always adopt the same angular positionwithin the vagina. If the internal portion is inserted being therebyrotated 180° relative to the right position, the female patient willeasily notice and feel that it does not fit correctly because of thebend described as being provided between the front and the rearsubsection. Additionally, the shape of the external portion may serve asan assistance and a guide so that the probe be inserted correctly.

In accordance with the invention, the external portion is configured asa handle. It serves to insert and to remove the internal portion. It isformed to be relatively flat so that it may be conveniently worn betweenthe legs. Its main dimensions are in the longitudinal center plane. As aresult thereof, it forms an abutment face. It is flat between the legs.As a result, it contributes to determining the correct positioning ofthe internal portion. It preferably accommodates the electronic circuitsof the processing electronics unit and more specifically an externallyrechargeable voltage supply. The external portion preferably has a clearmarking and/or shape so that the female patient is clearly apprised thatif she inserts the vaginal probe in this way, it will be positioned insitu being rotated 180° relative to the right position.

The crosspiece separates the external portion from the internal portion.It is clearly thinner than the two portions and quite short. The twoportions are rigidly connected together through the crosspiece. Inprinciple, it is also possible to provide a joint or a coupling in theregion of the crosspiece, more specifically in the transition part tothe external portion. The crosspiece is shaped like a rod, it preferablyis a tube portion.

The vaginal probe of the invention is relatively comfortable to wear. Itremains in place even if the patient is moving e.g., walking.Communication with a control apparatus is preferably wireless, whicheliminates the need for providing a supply line between the externalportion and the control apparatus and for somehow accommodating saidsupply line.

In a preferred development, the internal portion comprises sensorsmounted to its surface. The vaginal probe preferably has a processingelectronics unit, the sensors are connected to said processingelectronics unit and configured as electrically conductive areas and/oras pressure sensitive areas.

Thanks to its shape that conforms to the anatomy and to the integratedsensors, the internal portion permits to selectively register individualmuscles. These muscles may then be monitored and trained so that theactual muscles forming part of the pelvic floor muscles are allowed torespond and to be trained. The sensors are always placed in such amanner that they register the very muscles involved without taking themean.

The sensors can be configured in such a manner that they are allowed tocome into the best possible contact with the muscles to be registeredover possible the entire surface thereof. In the longitudinal directionfor example, the sensors may have a relatively long length. Othersensors are provided in other angular positions but on the same heightalong the longitudinal direction.

In a particularly preferred implementation, the external portion has anabutment face oriented transverse to the crosspiece, said abutment facebeing large enough to prevent the external portion from being insertedinto the vagina. This abutment face is preferably configured to beelongate, it is located between the legs of the female patient whenworn.

It has been found that it is very advantageous if the probe tapers inthe region of the crosspiece. This permits to achieve clear completionof the insertion process. Furthermore, this provision has as little aspossible an influence on the female anatomy. In any case, this isintended to prevent the muscle groups from being pre-stretched so thatthey are capable of gathering larger force during contraction.

In a particularly preferred embodiment there is provided that theinternal portion and the crosspiece form a single piece molded body,that thin electrical conductor areas are deposited on this molded body,one conductor area being provided for each sensor, and that an external,surrounding layer of electrically insulating material, more specificallya varnish layer, is provided, said varnish layer covering the moldedbody and the conductor areas so that only the areas intended for thesensors remain uncovered and the sensors remain freely accessible fromthe outside.

This permits to achieve a particularly advantageous manufacturingpossibility. The molded body may be hollow or solid and can be made fromany insulating material.

Configuring the internal portion as a hollow body provides the advantagethat the hollow body can be filled. As a result, the probe may be filledwith different weights.

In another preferred embodiment, a rounded groove is provided in therear subsection, it is oriented symmetrical about the longitudinalcenter plane. Sensors are also preferably disposed in the thusconfigured grooved portion. This permits access to the urethra muscleand provides space for the urethra.

In another preferred embodiment, the internal portion has, in the regionof the rear subsection and of the central section, a left hand side anda right hand side lateral arched cavity. Lateral sensors are preferablyprovided in the region of these lateral cavities. Overall probe fit isimproved, the probe being loaded inward rather than outward duringcontraction.

The concave arrangement of the lateral sensors of the vaginal probepermit intimate contact with the legs of the loop-shaped M. puborectalisindependently of the width of the Hiatus levatoris at rest or duringcontraction. The sensors, implemented as electrodes, are suited both forderivating action potentials and for electrically stimulating the muscleto improve its force of reflex contraction. This permits to enhance thecooperation between the abdominal muscles and the pelvic floor muscleswhen coughing, sneezing and so on.

It has been found out that it is preferable to releasably connect thefront subsection to the rear subsection. Differently configured frontsubsections can thus be connected to a rear subsection that remainsconstant. The shape of the front subsection can thus be adapted tovarious conditions of the individual female patient. This permits tocomply with the changing conditions in one and the same female patient,changes that may occur as a result of births and descents. An electricaland mechanical coupling e.g., a plug-connection, a screw connection or abajonet coupling may be preferably provided in the region of thecrosspiece.

The front subsection preferably serves for reference and for retainingthe internal portion within a vagina. In an improved implementation, itmay be provided with a reference sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages and characteristics of the invention will becomeapparent in the remaining claims and in the following non restrictivedescription of an embodiment thereof, given by way of example only withreference to the drawing. In said drawing:

FIG. 1 is a perspective view illustrating the vaginal probe of theinvention.

FIG. 2 is a top view of the vaginal probe.

FIG. 3 is a side view of the vaginal probe.

FIG. 4 is a front view of the vaginal probe, meaning a view of the frontsubsection.

FIG. 5 is a bottom view of the vaginal probe.

FIG. 6 is a top view of an internal portion of the vaginal probe viewedlike in FIG. 2.

FIG. 7 is a side view of the internal portion according to FIG. 6 viewedlike in FIG. 3.

FIG. 8 is a bottom view of the internal portion according to FIG. 6viewed like in FIG. 5.

FIG. 9 is a partial sectional perspective view illustrating a vaginalprobe in accordance with another embodiment.

DETAILED DESCRIPTION OF THE INVENTION

The vaginal probe has an external portion 20, an internal portion 22 anda crosspiece 24 that joins said two portions 20, 22 together and isconfigured as a short tube. The tube has a free length of about 5 to 20mm, preferably of about 10 mm and an outer diameter of about 5 to 7 mm.

The external portion 20 is configured as a handle which is taken hold offor inserting and removing the vaginal probe. It forms a hollow space 26for accommodating a processing electronics unit 28, a battery 30 and atneed other electronic components. A three-dimensional sensor that isresponsive to the earth's gravity field (e.g., ADXL 202 of AnalogDevices Inc.) is integrated in a preferred embodiment. This sensorpermits to continuously register the position of the vaginal probe inspace and, as a result thereof, in situ. The hollow space 26 isaccessible via a flap 27. Electrical external contacts 29 are providedfor charging the built-in accumulators (batteries). The external portion20 is formed substantially like a flat parallelepiped or like a cushion.It substantially consists of a thin shell so that it is as light aspossible and that the hollow space 26 may be configured to be as largeas possible. It is implemented so as to be quite flat for occupying butvery little space between the legs. In a preferred embodiment, theexternal portion 20 is formed in such a manner that a clear distinctioncan be made between the front (in front of the legs of a female patient)and the back, exhibiting e.g., an asymmetry with regard to thecrosspiece 24 in its longest extension. As a result, the female patientwill understand more easily that the e.g., longer part of the externalportion 20 must point vertically upward upon correct insertion of thevaginal probe.

The internal portion 22 is symmetrical about a longitudinal center plane32. Said plane passes through the central axis 33 of the rod-shapedcrosspiece 24 and extends between the legs of a female patient wearingthe vaginal probe. The external portion 20 has its main dimensions inthis longitudinal central plane 32. In the exemplary embodiment shown,the longitudinal central plane 32 is concurrently a plane of symmetry ofthe external portion 20 and of the crosspiece 24.

The internal portion 22 has cross sectional areas the cross sectionalarea 34 of which is shown in the Figs. This cross sectional area and allthe other ones are oriented at right angles to the longitudinal centerplane 32 and across the longitudinal direction of the vaginal probe. Thelongitudinal direction is oriented parallel to the axis 33 of therod-shaped crosspiece 24. The cross sectional area 34 is oriented atright angles to the axis 33 of the rod-shaped crosspiece 24.

As shown in the Figs., the internal portion 22 is quite flat. Itgenerally has a shape remotely resembling a shoespoon. The crosssectional area 34 has a height dimension H oriented in the direction ofthe longitudinal center plane 32 and extending across the crosspiece 24and a width dimension B that is determined transverse to thelongitudinal center plane 32. As can be seen from the Figs., the widthin the region of the cross sectional area 34 is at least six times theheight H. In all the possible cross sectional areas that are parallel tothe cross sectional area 34, the width B is at least twice the height H.The height H is selected to be as small as possible, in the exemplaryembodiment it is 10 mm maximum. The width varies between 43 and 20 mm.

To provide a better description, the internal portion 22 will now bedivided into subsections. It has a front subsection 36, a centralsection 38 and a rear subsection 40 that is connected to crosspiece 24.These subsections 36 through 40 integrally merge with each other. Asmore specifically shown in FIG. 3, in which the longitudinal centerplane 32 coincides with the plane of the paper, the rear subsection 40is oriented substantially in the direction of the crosspiece 24. Thecentral section 38 has a curved orientation. The front subsection 36 isinclined at an angle a of about 30° to the extended direction of therear subsection 40 so that the angle between the front subsection 36 andthe rear subsection 40 is of about 150°. In the illustration of FIG. 3,the internal portion 22 generally has approximately the shape of anarch. In the illustration in accordance with FIG. 2, in which the widthdimension B lies in the plane of the drawing, the width dimension, whichtakes departure from the rear subsection 40, first increases on almost astraight line, passes through a respective left hand side and right handside arched cavity 41 before decreasing again at the beginning of thefront end of the central section 38, an approximately parabolic frontboundary line being given thereby, see FIG. 2.

In the transition between the front subsection 36 and the centralsection 38 there is formed a U-shaped recess 42 that is bounded relativeto the front portion 36. It has an overall area that is clearly smallerthan the area defined by the outer contour in the top view of FIG. 2,the area of the recess 42 being more specifically smaller than ⅓,preferably smaller than ⅕ of the overall defined area in the top view.Given the recess 42, the probe is better retained within a vaginabecause tissue portions located both above and underneath partially passthrough this recess and become superimposed. Therefore, in a particularimplementation of the internal portion 22, an emitting diode (LED) 68and a light sensitive receiving diode 70 are mounted into the slightlyopening, U-shape oriented legs of this recess 42 in such a manner thatthey are located directly opposite each other on the same level so thatthe light absorbed by the tissue can be continuously measured forregistering the oxygen saturation in the tissue. The recess 42 must notbe provided, it is also possible to make a vaginal probe without saidrecess 42.

The sensors will now be discussed herein after. In the front subsection36 there is provided a reference sensor 44 that is configured to becircular in the exemplary embodiment, said sensor being located betweenthe recess 42 and the front point of the internal portion 22 and havinga diameter of about 15 mm. In the embodiment shown it is located on thetop side of the vaginal probe that is visible in FIG. 2. On the sameside of the vaginal probe there are two oblong parallel first sensors46. They are located in immediate proximity to the longitudinal centerplane 32, in the region of a concave groove 53 and in the transitionarea between the rear subsection 40 and the central section 38. Theyform a partial grip around the urethra and are intended to register themeasured signals generated by the M. sphincter urethrae externus uponcontraction thereof.

In the same length position but on the side of the internal portion 22and of the respective one of the arched cavities 41 there are disposedtwo second sensors 48 for scanning the M. puborectalis. These sensorsare also striped and extend substantially in the longitudinal direction.Two third sensors 50 are mounted to the part of greatest width of theinternal portion 22. As can be seen from FIG. 5, they are located on thebottom side of the internal portion 22. They are located on either sideof the recess 42 and have a circular shape with a diameter of about 8mm. They are associated with the pelvic floor muscles. In the rearsubsection 40, there is disposed a fourth sensor 51 which extendssymmetrically substantially in the longitudinal direction to thelongitudinal center plane 32, said sensor coming to rest against thePars profunda of the M. sphincter ani externus, see FIG. 5.

Accordingly, the sensors 46–50 are provided in pairs, the sensor 51 andthe reference sensor 44 being single sensors. All of the sensors 44–51are disposed and configured so as to be symmetrical to the longitudinalcenter plane 32. The sensors of the same type, meaning for example thefirst two electrodes 46 and so on, are respectively built according tothe same principle.

A possible construction of the vaginal probe will be explained hereinafter with the help of the FIGS. 6–8. According to these, the internalportion 22 has an inner part 52 carrying the sensors 44–51 and theirsupply lines 58 as well as a body 54, which is formed around said innerpart 52 and is connected thereto, said body being preferablymanufactured by injection molding or any other casting process andsurrounding the inner part 52 except for the surfaces of its sensors44–51. The surfaces of the sensors 44–51 are flush with the surface ofthe body 54. For making this body 54, a suited plastic materialexhibiting good adhesion to the body tissue is selected. Appropriateplastic materials are those tolerated by the body such as silicone,polyethylene, acrylate and so on, in any case insulators.

As shown in the FIGS. 6–8, the inner part 52 consists of a flat carrier56 and of the sensors 44–51 connected thereto. The carrier 56 is flatand has substantially the shape of the internal portion as viewed fromthe top (see FIG. 5) with slightly reduced dimensions though so that thebody 54 is allowed to surround the carrier 56 with a wall of at leastsome millimeters thick. With their free surfaces which are visible fromthe top, the sensors project from the carrier 56 by this wall thicknessof the body 54. The carrier has circuit traces 58 through which thediscrete sensors 44–51 are connected to connecting points 60. Electriclines extending through the inner hollow or, in an alternative, outsidealong the rod-shaped crosspiece 24 into the hollow space 26 of theexternal portion 20, are connected to these connecting points 60. Theconnecting points 60 are provided in the number required by the sensorsfor performing the function, they are eight in the exemplary embodimentif the sensors are electrodes and at least ten if the signal is acquiredvia electrically operated pressure elements.

The inner part 52 may be manufactured in several different ways. Asshown in the FIGS. 6–8, the inner part 52 may be a cast plastic partthat is already configured to form all the sensors 44–51, electrodes inthis case, including their surfaces. This plastic part is now completelycoated with a conductive coating, for example by electroplating. Themetallic electrodes are also formed as a result thereof. In a furtherstep, partition lines are etched, they are for example cut out with alaser so that the electrodes are separated, one electrode beingconnected to but one connecting point 60. Put another way, theelectrodes and the connecting points 60 are insulated against each otherso that the desired conductor connections are preserved.

The method of manufacturing an introitus probe, more specifically avaginal probe, just described is suited for any probe, not only for theprobe in accordance with claim 1. The applicant makes the right offiling a divisional application for manufacturing such a probe aproviso. The method steps are the following: manufacturing a plasticpart in the form of what will later be the probe, coating said plasticpart with a conductive coating, more specifically by electroplating.Forming partition lines in the coating for separating and definingelectrodes so that one electrode is connected to at least one connectingpoint.

In another embodiment, the discrete sensors 44–51, electrodes in thiscase as well, are made from flat stampings of metal, such as medicalgrade special steel, and deposited onto a plastic carrier. They aredirectly connected via discrete conductors so that connecting points 60are not necessary. In an improved embodiment, these metallic electrodesare bowl-shaped, meaning they have a rim that projects downward towardthe carrier 56 only. The carrier 56 has channels mating with the rims ofthe electrodes engaging therein.

In another embodiment, a sheet metal blank is stamped or formed in sucha manner that it forms all the sensors 44–51, electrodes again. It isthen coated e.g., filled, with plastic. Next, material of the sheetmetal blank is removed e.g., with a laser so that the electrodes andtheir supply lines are separated from each other.

The sensors 44–51 are for example pressure sensitive membranes orelectronic pressure elements, preferably combined with metallicelectrodes that are disposed on their outer surface. They are integratedin the surface of the vaginal probe so as to provide a form-positive fittherewith. In the combined implementation, each sensor must be supplied,besides the measuring line, by two supply lines, only two of which mustlead to the electronics unit in the external portion 20. Each sensore.g., the sensor 44, can be used for reference pressure.

FIG. 9 shows another exemplary embodiment the manufacturing of which isparticularly advantageous. A preferably single piece molded body alreadyhaving the shape of the finished probe is first produced. It forms inone piece the internal portion 22 and the crosspiece 24. At the end ofthe crosspiece it advantageously has a connection piece for connectionwith the external portion 20. Thin electric conductor areas 72 aredeposited onto this molded body. The entire molded body is for exampleelectroplated e.g., chromium plated. Partition lines are then made usinga laser, meaning the discrete conductor areas are formed andelectrically separated from each other. The conductor areas have in anycase a conductor region on the crosspiece 24 so that they may becontacted at the end of the crosspiece i.e., from the external portion20. The conductor areas 72 are preferably larger than the areas requiredfor the sensors 44–51, they are not allowed to be smaller though. Anexternally surrounding layer 76 of electrically insulating material,more specifically a varnish layer, covers the conductor areas 72 and theareas exposed by the laser, but does not cover the areas of the sensors44–51 which remain bare. As a result, the sensors are freely accessiblefrom the outside. This layer 76 is only illustrated in parts in FIG. 9.In the front subsection 36, it is shown completely, in the rearsubsection 40 it has been removed for showing the conductor areas 72 andthe partition lines 74. The conductor areas 72 located side by side thatcan be seen in the upper portion of FIG. 9 are connected to the urethraelectrodes 46 or form these in parts, respectively.

In still another embodiment the sensors 44–51 are formed by pressuresensitive membranes or electronic pressure elements that carry theelectrodes on their surface and are integrated into the surface of thevaginal probe so as to provide a form-positive fit therewith. In thisimplementation, each sensor must be supplied, besides the measuringline, by two supply lines, only two of which must lead to theelectronics unit in the external portion 20. The sensor 44 can be usedas a reference pressure.

Continence can also be produced by mechanical weight load. Preferably,the weight of the internal portion 22 can be varied by suited means, forexample by filling hollow spaces or by adding weights. The centroid ispreferably provided in proximity to the urethra, meaning of the concavegroove 53.

FIG. 1 still illustrates a separate control apparatus 78 to a muchreduced scale. It has a corresponding emitter and receiver and theprocessing electronics unit 28 and display means 80.

1. A vaginal probe, more specifically for diagnostis and therapy ofincontinence, with an external portion, an internal portion, and acrosspiece joining said external and internal portions together, saidexternal portion being configured to be a handle and said internalportion being configured as a generally rounded body, wherein saidinternal portion a) is oriented symmetrically about a longitudinalcenter plane which is oriented between the legs of the female patientwhen the vaginal probe is inserted, b) shows cross sections taken inplanes running crossways to said longitudinal center plane and saidcrosspiece, wherein in said cross sections, a height dimension H, whichis determined parallel to the longitudinal center plane, is at most halfa width B, which is determined across said longitudinal center plane,and c) comprises a front subsection distal from the external portion, acentral section and a rear subsection, the central section being curved,the rear subsection being connected to the crosspiece, said frontsubsection and said rear subsection being integrally joined togetherthrough the central section and said front subsection and said rearsubsection being inclined to each other at an angle of 170–100°, whereinsaid internal portion comprises sensors on its surface.
 2. The vaginalprobe in accordance with claim 1, wherein the length of the internalportion of the vaginal probe is at least 75 mm.
 3. The vaginal probe inaccordance with claim 1, wherein the external portion forms an abutmentface which is oriented transverse to the crosspiece and is large enoughto prevent the external portion from being inserted into the vagina. 4.The vaginal probe in accordance with claim 1, wherein the vaginal probeis tapered in the region of the crosspiece.
 5. The vaginal probe inaccordance with claim 1, further comprising a processing electronicsunit, wherein the sensors are connected to the processing electronicsunit and are configured to be electrically conductive areas and/orpressure sensitive areas.
 6. The vaginal probe in accordance with claim1, wherein the external portion accommodates an emitter and a receiverfor electromagnetic waves and that a separate control apparatus having acorresponding emitter and receiver and comprising display means for therecorded measurement signals is provided.
 7. The vaginal probe inaccordance with claim 1, wherein the internal portion and the crosspieceform a single piece molded body, wherein thin electrical conductor areasare deposited on said molded body, one conductor area being provided foreach sensor, and wherein an external, surrounding layer of electricallyinsulating material is provided, said insullating material layercovering the molded body and the conductor areas so that only the areasintended for the sensors remain uncovered and the sensors remain freelyaccessible from the outside.
 8. The vaginal probe in accordance withclaim 1, wherein a concave groove that is symmetrical about thelongitudinal center plane is provided in the rear subsection.
 9. Thevaginal probe in accordance with claim 1, wherein internal portion has,in the region of the rear subsection and of the central section, a lefthand side and a right hand side lateral arched cavity.
 10. The vaginalprobe in accordance with claim 1, wherein the internal portioncomprises, in its central section and/or in its front subsection, arecess having an area that is smaller than half the overall areadefining the outer contour of said internal portion as viewed from thetop.
 11. The vaginal probe in accordance with claim 1, wherein thevaginal probe has, in the region of said crosspiece, a cross sectionalarea that is at most one third of the cross sectional area of the othertwo portions.
 12. The vaginal probe in accordance with claim 1, whereinthe vaginal probe has, in the region of said crosspiece, a crosssectional area that is at most 10% of the cross sectional area of theother two portions.
 13. The vaginal probe in accordance with claim 1,wherein the internal portion and the crosspiece form a single piecemolded body, wherein thin electrical conductor areas are deposited onsaid molded body, one conductor are being provided for each sensor, andwherein an external, surrounding layer of electrically insulatingmaterial in the form of a varnish layer is provided, said varnish layercovering the molded body and the conductor areas so that only the areasintended for the sensors remain uncovered and the sensors remain freelyaccessible from the outside.